'Nano' ingredients to be judged on case-by-case basis

The Food and Drug Administration on June 24 issued new guidance for industry related to the use of nanotechnology in manufacturing F.D.A.-regulated products. Three final guidance documents were released, which presented the agency’s current thinking on nanotechnology in general, on nanotechnology in food and food packaging, and on nanotechnology in cosmetics. A draft guidance concerning nanotechnology in the manufacture of food for consumption by animals also was issued and comments sought.

Nanotechnology is an emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers (a nanometer is one-billionth of a meter). The F.D.A. noted the technology has a range of potential applications such as improving the packaging of food.

“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said F.D.A. Commissioner Margaret A. Hamburg, M.D., on issuing the guidance documents. “We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.”

All four guidance documents encouraged manufacturers using nanotechnology to consult with the agency before taking their products to market.

“Consultations with the F.D.A. early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product,” the F.D.A. said.

The final guidance related to nanotechnology and food is titled “Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances, including food ingredients that are color additives.” The title reflected the intent to provide guidance on all emerging technologies and significant manufacturing changes, including but not limited to nanotechnology.

The guidance alerted manufacturers to be aware of the potential impact of any significant manufacturing process changes, including changes involving use of nanotechnology, on the safety and regulatory status of food substances. The documents also described considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the F.D.A.

The information included four general recommendations to food and food packaging manufacturers.

Four steps to success

The first related to the use of food substances subject to food additive or color additive regulations. The F.D.A. said whenever there has been a significant manufacturing process change for such a food substance, manufacturers should determine what changes have been made to the identity of the food substance as a result of the change in manufacturing process, including its physiochemical structure and properties, purity and impurities.

Manufacturers, taking into account any impact of the change in the identity of the food substance, should conduct a safety assessment for the use of the food substance. Manufacturers also should consider whether the use of the food substance is authorized under a food additive or color additive regulation.

The F.D.A. then encouraged manufacturers to consult with the agency about their conclusions about the impact of the significant manufacturing change on the safety and regulatory status of the use of the food substance and make an appropriate regulatory submission to the F.D.A. “as circumstances warrant.”

The second recommendation related to the use of food contact substances for which there is in effect an existing food contact notification (F.C.N.). The F.D.A. indicated a new notification should be submitted “if substantive changes are made in the specifications for the food contact substance or if significant changes are made in the manufacturing method that results in substantive changes in the identity of the product or its impurities, and/or levels of impurities.”

The F.D.A. said manufacturers should determine what changes have been made to the identity of the food contact substance as a result of a manufacturing process change. Taking this into account, the manufacturer should conduct a safety assessment for the use of the food contact substance. The manufacturer also should consider whether the substance would or would not fall within the scope of an existing F.C.N.

The F.D.A. said the food contact substance would not be within the scope of an existing F.C.N. if “the identity of or the conditions of use of the food contact substance are significantly different from those described in a previously submitted notification, or the food contact substance is no longer of appropriate food grade as a result of impurities introduced into the food contact substance by the change in manufacturing process.”

In this instance also, manufacturers were urged to consult with the F.D.A. about their conclusions and make an appropriate regulatory submission to the F.D.A. as circumstances warrant.

The third and fourth recommendations concerned nanotechnology in relation to food substances that are generally regarded as safe (GRAS) or for which manufacturers seek a GRAS status. In both instances, manufacturers were encouraged to determine what changes may have been made to the identity of the food substance as a result of the change in manufacturing process. Taking into account any impact of the change in identity of the food substance, manufacturers should then conduct a safety assessment for the use of the food substance, and, of course, consult with the F.D.A. about their conclusions.

The F.D.A. elaborated, saying, “In the specific instance of nanotechnology, a food substance manufactured for the purpose of creating very small particle sizes with new functional properties likely would not be covered by an existing GRAS determination for a related food substance manufactured without using nanotechnology. A determination that a particular use of a substance is GRAS requires both technical evidence of safety and a basis to conclude that this technical evidence of safety is generally known and accepted. At present, for nanotechnology applications in food substances, there are questions related to the technical evidence of safety as well as the general recognition of that safety, which are likely to be sufficient to warrant formal premarket review and approval by F.D.A., rather than to satisfy criteria for GRAS status.”

The F.D.A. noted where an existing GRAS determination does not apply, a separate determination of GRAS status for the use of the food substance would depend both on technical evidence of safety and on general recognition of safety (in other words, this evidence being both generally available and accepted by qualified experts).

“It is prudent to consult with us on any potential view that the available data and information could form a basis for a determination of GRAS status of a food substance that involves significant manufacturing changes, including but not limited to those involving nanotechnology or other emerging technologies,” the F.D.A. explained. “Such technologies could be so new as to preclude a consensus among experts that the use of a food substance manufactured using that technology is safe, thus precluding a determination that the use of the food substance is GRAS. Therefore, it is likely that premarket review and approval of the food substance on a case-by-case basis by the agency is warranted.”

The F.D.A. said it will continue to develop its nanotechnology regulatory program that will enhance the agency’s scientific capabilities. It said would develop additional guidances for industry as needed.

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